Guided Therapeutics, after receiving a not-approvable letter for its LuViva Advanced Cervical Scan's pre-market approval (PMA) application, is planning to seek an independent panel review from the US Food and Drug Administration (FDA).
The company said it will work with FDA to successfully resolve and address the issue of its LuViva Scan.
Guided Therapeutics president and CEO Mark Faupel said they are disappointed that the FDA has issued a not-approvable letter after previously telling the company that a panel review of LuViva would not be necessary since the agency understood LuViva’s technology, it understood the clinical application and had also reviewed similar devices in the past.
"The company plans to focus more on European and Asian regulatory approvals, while continuing to aggressively pursue approval in the US," Faupel said.
LuViva Cervical Scan is designed as a painless test which utilizes proprietary technology to detect cancers and precancers quickly by analyzing light reflected from the cervix.
The technology distinguishes normal and diseased tissue by detecting biochemical and morphological changes at the cellular level.